Bicameral Pact Uses Market Forces To Push Compounders Toward Voluntary Federal Oversight Lawmakers late Wednesday (Sept. 26) struck a bicameral, bipartisan drug compounding agreement that departs from previous proposals by ditching volume limits and a three-part test in favor of a voluntary regulatory scheme for sterile compounders.

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Are we there yet? Bicameral Congressional group posts news about a track-and-trace agreement September 26, 2013

Regulation of compounding pharmacies will be included in the new Drug Quality and Security Act

 

Confirming that, indeed, Congressional committees have been working hard behind the scenes to completea compromise draft legislation that will encompass both the longstanding effort for national rules on trackingpharmaceutical shipments, and the more recent effort to give FDA more authority to regulate compounding pharmacies, several Congressmen issued news releases on Sept. 25 announcing their success. The actual bill remains to be revealed, at least as of early on Sept. 26. 

 

Senator Tom Harkin (D-IA), chairman of the Senate Health, Education and Labor Committee, issued astatement that commended “the bipartisan spirit that brought this compromise proposal together” in the form of what will now be called the Drug Quality and Security Act.  “Today we are taking a notable step toward completing the important work of improving the security of our pharmaceutical supply chain and clarifying the regulation of drug compounding,” said a statement from Fred Upton (R-MI), chairman of the House Energy and Commerce committee. “This step will help us protect the health and safety of the American people,” said Energy and Commerce Committee Chairman Fred Upton (R-MI).

 

Interestingly, the issue of drug compounding seems to have superseded that of track-and-trace legislation in the discussions. The Senate bill put forward earlier this year included regulation of compounding; the House bill did not. Given that track-and-trace legislation has been debated and wrestled with since around 2006, while the compounding topic only appeared within the past year, there was a risk that the ongoing legislative efforts for track and trace could have been derailed by the compounding issue.

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FDA Law Blog - HHS Issues Refill Reminders Guidance Ahead of Compliance Deadline; FDA’s Fifth Annual Report to Congress on 505(q) Citizen Petitions

By Jeffrey N. Wasserstein & Alexander J. Varond –

Last week, ahead of the September 23, 2013 compliance deadline for its HITECH final rule (also referred to as the “Omnibus Final Rule”), the Department of Health and Human Services issued guidance  entitled “The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual.”  In prior posts, we discussed the HITECH final rulehere, here, and here.  The guidance, as you guessed it, addresses the refill reminder exception, from the Omnibus Final Rule, and its two prongs:  (1) whether the communication is about a “currently prescribed drug or biologic,” and (2) if the communication involves financial